Microbiology Group Leader, Validation

JOB SUMMARY

The Microbiology Group Leader, Validation is responsible for aiding the Microbiology leadership in the day-to-day and strategic functions of the Validation group within the Microbiology department. The Microbiology Group Leader, Validation is responsible for prioritizing work to meet customer expectations, scheduling, and ensuring all work is performed in compliance with the quality, health and safety objectives of the company. The Microbiology Group Leader, Validation provides technical support and training to Microbiologists in the lab and out. The Microbiology Group Leader, Validation, assists with the responsibility for improving production efficiency while meeting the financial and service goals of the laboratory.

The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.

PRIMARY DUTIES AND RESPONISIBITIES

• Schedule projects assigned to the Validation group, to ensure that work meets the required timelines.


• Assists with the development and implementation of process improvement initiatives that promote increased productivity for the Validation group.


• Coordinates with Microbiology leadership  to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).


• Assists with the writing and reviewing of methods, protocols and notebook studies to ensure all technical aspects of the documents are clear before testing begins.


• Coordinates with the Chief Science Officer, Microbiology Director, and other technical resources to perform feasibility and implement new test methods and equipment as needed.


• Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with Microbiology leadership and Microbiologists.


• Assists Microbiology leadership  with devising and developing processes and methods for the solution of technical problems.


• Assists with the training and mentoring of Microbiologists within the lab and out.


• Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.


• Assists with ensuring that laboratory supplies, consumables, standards are available to perform the analyses within the required project turnaround time.


• Communicates project delays, quality and or technical issues to the Microbiology leadership and/or Client Services Team, as needed.


• Reviews lab nonconformance (investigation and deviations) with Microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.


• Provides regular ongoing performance feedback while serving as a trainer and mentor.


• Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.


• Follows all safety rules and regulations.


• Follows all cGMP rules and regulations.


• Documents work in a clear and organized manner.


• Maintain a clean and orderly laboratory environment.


• Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

REQUIREMENTS & QUALIFICATIONS

• Master’s and/or Bachelor’s degree in Microbiology or a related discipline


• Must have 5 years of experience in Microbiology or related field


• Must have laboratory experience and knowledge of cGMPs and related compliance regulations and guidances.


• Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS and ELN.


• Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.


• Demonstrated skills in laboratory techniques

MINIMUM SKILLS REQUIREMENTS

• Must be a team player with integrity and concern for the quality of Company products, services and staff members


• Self-starting, motivated person who possesses excellent interpersonal skills


• Ability to assume a leadership role in the laboratory


• Ability to effectively interact with all departments within the company and with client personnel